Genentech’s Post

Found this press release from FDA's CBER on partial #hearttransplantation interesting and noteworthy (especially given the FDA indicates they've received questions on this topic as of late; 🤔 perhaps a timely therapeutic or surgical technique in development that I'm not aware of touches on this question?). Whether #donor-derived human #allograft heart material falls under the HCT/P regulations found in 21 CFR 1271 is dependent on how the material is isolated, manipulated and used, but in general allograft heart valve is considered an HCT/P regulated under Section 361 of the PHS Act. As the heart itself is a vascularized solid organ regulated by CMS, in its entirety it IS NOT an HCT/P, however a heart valve component that is both minimally manipulated and intended for homologous use (while not having a systemic effect or an effect based on the metabolism of the implanted cells) IS an HCT/P as defined at 21 CFR 1271.10(a) and would thus be subject to #GoodTissuePractice requirements defined therein. Interested to see how progress in the field of #cardiothoracicsurgery may impact regulatory considerations for transplanted materials such as these. #transplantation #regulatoryaffairs #HCTPs #cGTP #donor #allogeneic #cardiacsurgery #cardiothoracicsurgery https://lnkd.in/gSKzTYYF

Earlier this week, the FDA approved aflibercept-jbvf (Yesafili) and aflibercept-yszy (Opuviz), the first interchangeable #biosimilars for aflibercept (Eyela). These #medications are used to #treat neovascular age-related macular degeneration, macular edema following #retinal vein occlusion, diabetic macular edema, and diabetic #retinopathy. https://lnkd.in/eYX9Tm5s

Eylea biosimilar receives FDA approval Formycon's Eyelea biosimilar Ahzantive, or aflibercept-mrbb, has received FDA approval to treat patients with diabetic retinopathy, neovascular age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion. The approval was based on data that the biosimilar had no meaningful difference in efficacy and safety from the reference product. https://lnkd.in/gff9KR7V

https://lnkd.in/ehukh9Wv FDA approved Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) as interchangeable biosimilars to Eylea (aflibercept). Aflibercept products work by inhibiting vascular endothelial growth factor (VEGF) which prevents abnormal blood vessel growth within the eye. By blocking VEGF, aflibercept products can slow down or reduce damage to the retina and help preserve vision.

OT posts that Vabysmo (faricimab-svoa), Genentech's treatment for nAMD, DME, and RVO, has just been approved by the FDA in 6.0 mg single-dose prefilled syringes, offering physicians a ready-to-use option. #Ophthalmology #AgeRelatedMacularDegeneration #DiabeticMacularEdema #RetinalVeinOcclusion

Genentech announced the FDA has approved faricimab-svoa (Vabysmo) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). The single-dose prefilled syringe offers the same medication as existing Vabysmo vials, and offers physicians an alternative, ready-to-use option. It will continue to be available in a 6.0 mg vial. Read More: https://ow.ly/Z9Jf50SwTvC

This technology is such a life saver.

New paper from our team (Pharmacology and Internal Medicine) : Risk of flare in patients with SLE in remission after hydroxychloroquine or chloroquine withdrawal https://lnkd.in/eJ4AeReF #STP #TDM #Pharmacology #lupus

Solutions is on the way. Good things worth waiting for.

The prefilled syringe of #Vabysmo will become available in the coming months. It treats age-related macular degeneration, diabetic macular edema and macular edema following retinal vein occlusion. #FDA https://lnkd.in/eUaEieup